G/SPS/N/CAN/1280  
 
26 November 2019  
(19-8102) Page: 1/3 
Committee on Sanitary and Phytosanitary Measures  Original: English/French  
 
  
NOTIFICATION  
1. Notifying Member:  CANADA  
If applicable, name of local government involved:   
2. Agency responsible:  Health Canada  
3. Products covered (provide tariff item number(s) as specified in national 
schedules deposited with the WTO; ICS numbers should be provided in addition, 
where applicable):  Methyl -p-hydroxybenzoate (methyl paraben), propyl -p-
hydroxybenzoate (propyl paraben), and their sodium salts (sodium salt of methyl -p-
hydroxybenzoic acid and sodium salt of propyl -p-hydrox ybenzoic acid)  (ICS Code: 
67.220.20)  
4. Regions or countries likely to be affected, to the extent relevant or practicable : 
[X] All trading partners   
[ ] Specific regions or countries:   
5. Title of the notified document:  Health Canada's Proposal to Revise Permitted Uses of 
the Food Additives Methyl Paraben, Propyl Paraben and their Sodium Salts in Various 
Foods - Reference Number: NOP/ADP -0033. Language(s):  English and French . Number 
of pages:  9 
https://members.wto.org/crnattachments/2019/SPS/CAN/19_6669_00_e.pdf  
https://members.wto .org/crnattachments/2019/SPS/CAN/19_6669_00_f.pdf  
6. Description of content:  Health Canada's Food Directorate is proposing modifications to 
the parabens' food uses with the objective of ensuring that these uses are up to date and 
reflective of actual uses  in foods sold in Canada. Consequently, Health Canada intends to 
revise the food categories and maximum levels of use for methyl -p-hydroxybenzoate 
(methyl paraben), propyl -p-hydroxybenzoate (propyl paraben), and their sodium salts 
(sodium salt of methyl -p-hydroxybenzoic acid and sodium salt of propyl -p-
hydroxybenzoic acid) in Part 2 of the List of Permitted Preservatives  
(https://www.canada.ca/en/health -canada/services/food -nutrition/food -safety/food -
additives/lists -permitted/11 -preservatives.html ) as described in the information 
document.  
The purpose of this communication is to publically announce the Department's i ntention 
in this regard and to provide the appropriate contact information for any inquiries or for 
those wishing to submit any new scientific information relevant to the safety of these food 
additives.  
7. Objective and rationale: [X]  food safety, [  ] animal health, [  ] plant protection, 
[ ] protect humans from animal/plant pest or disease, [  ] protect territory from 
other damage from pests.   G/SPS/N/CAN/1280  
 
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  8. Is there a relevant international standard? If so, identify the standard:  
[X] Codex Alimentarius Commission (e.g.  title or serial number of Codex 
standard or related text) : Codex General Standard for Food Additives (GSFA)  
[ ] World Organization for Animal Health (OIE) (e.g.  Terrestrial or Aquatic 
Animal Health Code, chapter number) :  
[ ] International Plant Protection Convention (e.g.  ISPM number) :  
[ ] None  
Does this proposed regulation conform to the relevant international standard?  
[ ] Yes   [X] No  
If no, describe, whenever possible, how and why it deviates from the 
international  standard:  The food categories and maximum levels proposed by the Food 
Directorate are generally in line with those established by regulatory bodies who have 
more recently assessed permitted parabens maximum levels in food.  Differences that 
exist between international regulations and those that the Food Directorate is proposing 
are the following: (1) the specific parabens that are allowed in foods (methyl - and ethyl - 
paraben) are permitted in the European Union and by the Codex General Standard for 
Food Ad ditives (GSFA); (2) the food categories in which they are permitted (more 
extensive in the United States of America and Codex GSFA); and (3) the levels of 
parabens in finished foods (higher concentrations in general are permitted in finished 
foods by other  authorities, with the exception of enzyme preparations where 
concentrations are lower in the European Union).  
The difference in specific parabens allowed between Canada, the European Union and the 
Codex GSFA is the result of the Food Directorate's assessm ent of new toxicological 
evidence on the parabens, which does not support the conclusions made by JECFA and 
EFSA in their respective assessments. Therefore, the Food Directorate includes propyl 
paraben in its ADI for the parabens and considers that current  propyl paraben uses by 
the food industry are acceptable from a food safety perspective. Contrary to the European 
Union and Codex GSFA, the Food Directorate has never received a request from the food 
industry for approval of its use in foods sold in Canada  and therefore ethyl -paraben is not 
currently permitted.  
9. Other relevant documents and language(s) in which these are available:  
Health  Canada's Food and Nutrition - "Public Involvement and Partnerships" Website, 
posted 15 November 2019 (available in English and French):  
https://www.canada.ca/en/health -canada/services/food -nutrition/public -involvement -
partnership s.html  (English)  
https://www.canada.ca/fr/sante -canada/services/aliments -nutrition/participation -public -
partenariats.html  (French)   
10. Proposed date of adoption (dd/mm/yy) : The proposed food additive modification(s) 
will be legally enabled once published in Health Canada's Lists of Permitted Food Additives  
(https://www.canada.ca/en/health -canada/services/food -nutrition/food -safety/food -
additives/lists -permitted.html ). 
Proposed date of publication (dd/mm/yy) :  
11. Proposed date of entry into force: [  ] Six months from date of publication , 
and/or  (dd/mm/yy) : The food additive modification(s) noted in this document come 
into force the day they are made to the Lists of Per mitted Food Additives  
(https://www.canada.ca/en/health -canada/services/food -nutrition/food -safety/food -
additives/lists -permitted. html). 
[ ] Trade facilitating measure   G/SPS/N/CAN/1280  
 
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  12. Final date for comments: [  ] Sixty days from the date of circulation of the 
notification and/or (dd/mm/yy) : 28 January 2020  
Agency or authority designated to handle comments: [  ] National Notification 
Authority, [X]  National Enquiry Point. Address, fax number and e -mail address 
(if available) of other body:   
13. Text(s) available from: [  ] National Notification Authority, [X]  National Enquiry 
Point. Address, fax number and e -mail address (if available)  of other body:   
"Health Canada's proposal to Revise Permitted Uses of the food additives Methyl Paraben, 
Propyl Paraben and their Sodium Salts in Various Foods - Reference Number: NOP/ADP -
0033" is available through the following weblink:  
https://www.canada.ca/en/health -canada/services/food -nutrition/public -involvement -
partnerships/proposal -revise -permitted -food-additives -methyl -paraben -propyl -
paraben.html  (English)  
https://www.canada.ca/fr/sante -canada/services/aliments -nutrition/participation -public -
partenariats/proposition -reviser-autorisees -additifs -alimentaires -methylparabene -
propylparabene.html  (French)  
Canada's Notification Authority and Enquiry Point  
Technical Barriers and Regulations Division  
Global Affairs Canada  
111 Sussex Drive  
Ottawa (Ontario) K1A 0G2  
Canada  
Tel: +(34 3) 203 4273  
Fax: +(613) 943 0346  
E-mail: enquirypoint@international.gc.ca